Reported Jun 19, 2019 · Terminated
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506
Is this the product you have?
- Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle
- NDC16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
- Lot codes and dates
Lot #s: 17H00217H00517H00617H00717H02617H027Exp. 08/201917J01017J013Exp. 09/201917K01417K015Exp. 10/201917L015Exp. 11/201917M026Exp. 12/201918A02818A031Exp. 01/202018B026Exp. 02/202018E003Exp. 05/2020
- Amount recalled
- 233,388 bottles
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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